Clinical Trial · NCT01774760

Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

Overview

The results of previous studies suggest further development of \[18F\]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of \[18F\]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

Sponsor

Turku University Hospital

Phase

Phase 2

Contacts

Heikki Minn, Professor (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01774760

Drug / Compound

FDG

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

EF5

Isotope(s):

Target(s):

Hypoxia

Ligand Class: Small Molecules

Eligibility

Inclusion

* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm
Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck
Patients with nodal neck metastases of head and neck cancer are eligible
Mental status: Patients must be able to understand the meaning of the study

Exclusion

* Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.
Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.
Patients with organ metastases in liver, bone, brain or lung.
Patient must not have an uncontrolled serious infection